Bausch + Lomb has acquired the assets and U.S. rights for Zirgan® (ganciclovir ophthalmic gel 0.15%) from Sirion Therapeutics, Inc. In 2007, Sirion Therapeutics acquired a license for the Zirgan product technology and trademark from Laboratoires Théa, headquartered in France, for the U.S. market.
Zirgan was approved by the U.S. Food and Drug Administration (FDA) in 2009 as a topical anti-viral for the treatment of acute herpetic keratitis (corneal ulcers).
“We’re intensely focused on understanding and serving the needs of our customers and their patients,” said Brent L. Saunders, chief executive officer, Bausch + Lomb. “Our acquisition of Zirgan is an important step in further expanding our innovative product portfolio, which spans the ophthalmic spectrum.”
Herpetic keratitis, caused by the herpes simplex virus (HSV), is a significant cause of corneal blindness and a leading indication for corneal transplants. Approximately 50,000 new and recurrent cases are treated in the United States each year. After the initial outbreak, HSV becomes a latent infection in the trigeminal ganglion and possibly the cornea, with repeated recurrences that frequently lead to corneal scarring and ocular inflammation, increasing the risk of blindness.
Ganciclovir gel has been the standard-of-care therapy in Europe for more than a decade, developed and sold worldwide under the Virgan® trademark by Laboratoires Théa. Unlike older anti-viral pharmaceuticals which affect both healthy and infected cells, Zirgan selectively targets the replication of HSV DNA. It has a low corneal toxicity profile to provide patients with comfort and relief.
Sirion introduced Zirgan to the U.S. market earlier this year, representing the first innovation in ocular anti-viral therapy in the U.S. in more than 30 years.
“Our acquisition of Zirgan reflects our strategy to bring innovative products to the ophthalmic community,” said Philip Gioia, head of North America Pharmaceuticals, Bausch + Lomb. “With its tolerability, convenience, and targeted anti-viral effect, we believe Zirgan will experience rapid adoption by U.S. physicians for the benefit of their patients.”
The FDA has designated Zirgan as an orphan drug, conveying special status for rare diseases or conditions that affect fewer than 200,000 patients in the U.S. The recommended dosing for Zirgan is one drop five times per day until the ulcer heals, and then one drop three times per day for seven days.
Zirgan is available by prescription through U.S. pharmacies, with more expected to carry the product in the coming months following its acquisition by Bausch + Lomb. It is also stocked with all major U.S. pharmaceutical wholesalers.
J.P. Morgan Securities, Inc. is acting as financial advisor and Proskauer Rose LLP is acting as legal advisor to Sirion Therapeutics with regard to the transaction. Nixon Peabody is acting as legal advisor to Bausch + Lomb. Financial terms of the acquisition were not disclosed.
